Trial reportRMD open2019
Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs.
Trial report in RMD open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01877668 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib), which is not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis
Who cites it
34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025Pooled it
- Pooled it
- Systematic literature review and network meta-analysis of therapies for psoriatic arthritis on patient-reported outcomes.BMJ open · 2023Pooled it
- Effects of bDMARDs on quality of life in patients with psoriatic arthritis: meta-analysis.BMJ open · 2022Pooled it
- Efficacy of Tofacitinib in the Treatment of Psoriatic Arthritis: A Systematic Review.Advances in therapy · 2021Pooled it
- Trial
- Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib.Arthritis research & therapy · 2021Trial
- Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.RMD open · 2020Trial
- Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis.RMD open · 2020Trial
- Trial
- Development and validation of the first needs-based quality of life measure for individuals with manifest Huntington's disease.Journal of neurology · 2026Article
- Therapeutic Windows Across the Psoriatic Arthritis Spectrum.Rheumatology and therapy · 2026Review
- Ultrasound Evaluation of Therapeutic Response to Tofacitinib and Upadacitinib in Patients with Rheumatoid Arthritis-Real-Life Clinical Data.Biomedicines · 2025Article
- Ivarmacitinib improves patient-reported outcomes across multiple domains in patients with active ankylosing spondylitis: aFrontiers in pharmacology · 2025Article
- Inhibition of the JAK-STAT Pathway in the Treatment of Psoriasis: A Review of the Literature.International journal of molecular sciences · 2024Review
- The Effect of JAK Inhibitors on Patient-Reported Outcomes in Psoriatic Arthritis.Mediterranean journal of rheumatology · 2024Article
- Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study.Arthritis research & therapy · 2023Article
- Inflammatory Cytokines in Psoriatic Arthritis: Understanding Pathogenesis and Implications for Treatment.International journal of molecular sciences · 2023Review
- Consensus on targeted drug therapy for spondyloarthritis.Rheumatology and immunology research · 2023Article
- The influence of adalimumab treatment on the systemic gene expression in patients with psoriatic arthritis - preliminary report.Archives of medical science : AMS · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objectives: Tofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). We evaluated patient-reported outcomes (PROs) in patients with PsA refractory to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and tumour necrosis factor inhibitor-naïve in a 12-month, phase III randomised controlled trial (OPAL Broaden [NCT01877668]). Methods: Patients (N=422) received tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg subcutaneously every 2 weeks or placebo advancing to tofacitinib 5 mg or 10 mg twice daily at month 3. Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences (MCID); and scores ≥normative values in: Patient Global Assessment of disease activity (PtGA), Pain, Patient Global Joint and Skin Assessment (PGJS), Short Form-36 Health Survey version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), EuroQol 5-Dimensions-3-level questionnaire (EQ-5D-3L) and Ankylosing Spondylitis Quality of Life (ASQoL) were determined. Nominal p values were cited without multiple comparison adjustments. Results: At month 3, PtGA, Pain, PGJS, FACIT-Fatigue, EQ-5D-3L, ASQoL and SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP) and vitality domain scores exceeded placebo with both tofacitinib doses (p≤0.05); SF-36v2 social functioning with 5 mg twice daily (p≤0.05). Percentages reporting improvements ≥MCID in PtGA, Pain, PGJS, FACIT-Fatigue, ASQoL and SF-36v2 PCS, PF, BP and general health scores exceeded placebo with both tofacitinib doses (p≤0.05) and were similar with adalimumab. Conclusion: csDMARD-IR patients with active PsA reported statistically and clinically meaningful improvements in PROs with tofacitinib compared with placebo at Month 3.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.